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The BD CTGCTV2 assay incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from:

• Chlamydia trachomatis (CT)
• . Neisseria gonorrhoeae (GC)
• . Trichomonas vaginalis (TV)

The assay may be used for detection of CT, GC and/or TV DNA in patient- or clinician-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens. The assay may also be used for the detection of CT and GC DNA in endocervical swab and Liquid-Based Cytology (LBC) specimens in ThinPrep PreservCyt Solution using an aliquot that is removed prior to processing for the ThinPrep Pap test.

The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis.

The BD CTGCTV2 assay is available for use on the BD MAX System or the BD COR System.

As with the existing BD CTGCTV2 for BD MAX System, K182692, the BD COR PX/MX (BD COR) high throughput system conducts sample extraction steps to isolate and concentrate DNA which is then amplified to detect specific sequences for diagnostic purposes.

The BD COR System is designed to allow the user to place clinical specimens directly into designated transport racks to be loaded into the System. Once the specimens are loaded, the System will perform the necessary pre-analytical steps such as vortexing, aliquoting into a molecular tube with the correct diluent, sorting/grouping of the secondary samples for testing by assay, pre-warming and cooling of the sample (where required), and transport of the sample into a molecular analyzer, where extraction, amplification and detection will take place.

Additionally, the steps of ordering tests on the instrument for specific samples will be managed directly by the user interaction with the Laboratory Information System (LIS), which communicates with the instrument.

Once the clinical specimens are received in the laboratory and loaded into the transport racks, the user will not be required to directly handle the specimen again prior to result reporting and removal from the system.

Here's a breakdown of the acceptance criteria and study details for the BD CTGCTV2 assay, based on the provided document:

Acceptance Criteria and Device Performance

The core of this submission focuses on demonstrating the substantial equivalence of the BD CTGCTV2 assay when run on the BD COR System to its previously cleared performance on the BD MAX System. Therefore, the acceptance criteria are implicitly tied to demonstrating comparable analytical and clinical performance between the two platforms.

Key Performance Metrics (Implicit Acceptance Criteria) and Reported Device Performance:

Study Information: BD CTGCTV2 Assay on BD COR System

This submission pertains to the BD CTGCTV2 assay being used on the BD COR System. The key study is a clinical agreement study and analytical performance studies designed to demonstrate that the performance of the assay on the BD COR System is equivalent to its already cleared performance on the BD MAX System (K182692).

1. A table of acceptance criteria and the reported device performance:
* See table above.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Analytical Performance (Precision & Reproducibility Test Set):
* Precision (within-laboratory): 72 replicates for each target (CT, GC, TV) at each of 4 concentration levels (MP, LP, HN, TN) for PreservCyt samples and 4 concentration levels for Urine samples. Total N is not explicitly stated as a single number but is derived. For example, for CT in PreservCyt, it's 72 * 4 = 288 data points.
* Reproducibility (multi-site): For each target and concentration level, 36 replicates per site across 3 sites (36 * 3 = 108 total replicates per target/level).
* Analytical Sensitivity Confirmation: 4 panel members (A, B, C, D) created with 1.5x LoD and 3x LoD for various target organisms and strains in pooled female urine, pooled vaginal swab, and pooled PreservCyt LBC matrix. The study compared performance between BD COR and BD MAX. The exact number of replicates for each panel member for this confirmation study is not explicitly stated as a total N, but implied to be sufficient for statistical comparison (mean Ct.Scores and 95% CIs are reported).
* Cross-Contamination: 540 positive samples and 540 negative samples for a total of 1080 samples.
* Clinical Agreement Study (Test Set):
* Sample Size: 433 independent panel members.
* Provenance: "Remnant urine specimens from the previous clinical trial for BD CTGCTV2 on BD MAX as well as urine specimens obtained from both internal and external collections were used for the comparison study." This suggests a retrospective collection of remnant urine specimens combined with potentially prospective collections from internal and external sources to create the clinical panels. The country of origin is not explicitly stated, but given the FDA submission, it can be inferred to be primarily US-based or at least compliant with US regulations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
* For the Precision, Reproducibility, Analytical Sensitivity, and Cross-Contamination studies: The ground truth was established by the known concentrations or presence/absence of organisms in contrived samples or spiked matrices. These are analytical studies, not clinical studies requiring expert interpretation.
* For the Clinical Agreement Study: The BD MAX System results served as the reference/ground truth. The positive or negative status of a panel member was defined by "≥2 out of 3 evaluable results obtained on the BD MAX." This is a comparator method, not direct expert consensus on patient samples. Therefore, no human experts were used to establish the ground truth for the clinical agreement study beyond the definition of the BD MAX as the reference standard.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* For the Clinical Agreement Study: The "ground truth" (reference comparator result from BD MAX) was established by "≥2 out of 3 evaluable results obtained on the BD MAX". This functions as a form of "consensus" or adjudication among multiple runs (3 aliquots) on the reference system.
* For the analytical studies (precision, reproducibility), ground truth was based on known concentrations, so no adjudication by a panel of experts was necessary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* No MRMC comparative effectiveness study was done. This device is an in vitro diagnostic (IVD) assay that detects nucleic acids. It's an automated molecular system, not an AI-assisted diagnostic tool that human readers would interpret. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Yes, this is a standalone performance study in the context of an IVD assay. The BD CTGCTV2 assay on the BD COR System is an automated system for qualitative detection of DNA. The studies described (analytical and clinical agreement) evaluate the performance of this automated system directly, without human interpretation of its diagnostic output. The output itself (positive/negative) is the final result.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* Analytical Studies (Precision, Reproducibility, Cross-Contamination, Analytical Sensitivity): The ground truth was based on known concentrations of purified organisms or specific strains spiked into negative matrices. This is an analytical ground truth.
* Clinical Agreement Study: The ground truth was the result from the legally marketed predicate device, the BD MAX System, determined by a "consensus" of ≥2 out of 3 evaluable results from the BD MAX. This is a (predicate) comparator ground truth.

8. The sample size for the training set:
* The document describes studies for validation and equivalency demonstration of the BD CTGCTV2 assay on the BD COR System compared to the BD MAX System. It does not mention "training sets" in the context of machine learning or AI models.
* For IVD assays, "training" typically refers to the initial development and optimization of the assay performed by the manufacturer. The data used for this developmental phase is not typically detailed in 510(k) summaries, which focus on formal validation studies.
* The assay itself incorporates "automated DNA extraction and real-time PCR," which are well-established molecular biology techniques, not typically "trained" in the AI sense.

9. How the ground truth for the training set was established:
* As noted above, the document does not describe a "training set" in the context of an AI/machine learning model. Therefore, this question is not applicable. The development of the PCR assay and its parameters would have involved extensive laboratory work by the manufacturer, but the "ground truth" for those developmental phases would be based on well-characterized materials and samples, similar to the analytical studies described for validation.

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